A Study of AK117 in Combination With Azactidine Plus Venetoclax in

Clinical Trial Summary

This is a phase 1b/2 study. All patients are diagnosed with Acute Myeloid Leukemia (AML), Eastern Cooperative Oncology Group (ECOG) performance status 0-3. The purpose of this study is to evaluate the safety and efficacy of AK117 + azacitidine + venetoclax in subjects with AML.

See also
	Status	Clinical Trial	Phase
	Recruiting	`NCT04429191` - JSP191 Antibody Conditioning Regimen in MDS/AML Subjects Undergoing Allogenic Hematopoietic Stem Cell Transplantation	Phase 1

See also

Status

Clinical Trial

Phase

Recruiting

NCT04429191 - JSP191 Antibody Conditioning Regimen in MDS/AML Subjects Undergoing Allogenic Hematopoietic Stem Cell Transplantation

Phase 1

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT06387420
Study type	Interventional
Source	Akeso
Contact	Jie Yang, MD
Phone	+86(0760)89873999
Email	jie.yang@akdsobio.com
Status	Not yet recruiting
Phase	Phase 1/Phase 2
Start date	April 29, 2024
Completion date	April 2027

A Study of AK117 in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms